Positive Phase III Data Means Xifaxan NDA Filing for NC-IBS Expected by End of June

Wednesday, May 5

Positive data from Phase III trials with Salix Pharmaceuticals’ Xifaxan 550 mg (rifaximin) antibiotic against nonconstipation irritable bowel syndrome (NC-IBS) have led the company to confirm plans for a relevant NDA filing with FDA by the end of June.

Presented at the recent annual “Digestive Disease Week” in New Orleans, data from the identically designed Target 1 and Target 2 trials showed that a 14-day course of the nonsystemic antibiotic was significantly better than placebo at providing relief from NC-IBS symptoms, for up to three months, Salix claims. Assessment of secondary endpoint data also showed the drug provided adequate relief from bloating for at least two of the first four weeks following the two-week treatment period. The statistically significant weekly findings in primary and key secondary endpoints were supported by the patients’ daily assessments of global IBS symptoms.